Canadian Government Agency Removes Barrier for Psilocybin Therapy

PALM BEACH, Fla., Dec. 16, 2020 /PRNewswire/ -- Health Canada, in a recent "breakthrough Exemption" has quietly expanded its list of who can legally possess and consume psilocybin-containing mushrooms by granting 16 health-care professionals the same exemptions it gave more than a dozen patients with terminal and mental illnesses, according to TheraPsil, a Victoria non-profit that has been behind the struggle to treat a list of mental health issues, including debilitating depression, PTSD and even terminal cancer patients. 

Psilocybin is currently being studied for its potential to treat various conditions such as anxiety, depression, obsessive compulsive disorder and problematic drug use. It is important to note that studies involving the use of Psilocybin require administration of the purified active ingredient in clinically supervised settings. As of right now, there are no approved therapeutic products containing Psilocybin in Canada. Active companies in news today include: Pure Extracts Technologies Corp. (CSE: PULL), Mydecine Innovations Group (CSE: MYCO), Revive Therapeutics Ltd. (OTCPK: RVVTF) (CSE: RVV), Numinus Wellness Inc. (OTCPK: LKYSF) (TSX-V: NUMI), Entheon Biomedical Corp. (OTCPK: ENTBF) (CSE: ENBI).

To legally possess and conduct activities with controlled substances in Canada, companies and research organizations must first obtain a controlled substances Dealer's License (or a Section 56 exemption for researchers (physicians, veterinarians and other researchers affiliated to universities and private industry) requiring a controlled substance for research purposes which include in vitro utilization, administration to animals and/or human clinical trials). This license authorizes the company or the organization to possess the controlled substances and to conduct activities specified by the license (such as production, packaging, sale, sending, transportation, delivery, laboratory analysis, research & development, clinical studies, import/export or distribution under special access program only). Controlled substances can only be imported or exported if the shipment is authorized by a permit issued by Health Canada. Only a holder of a valid controlled substances Dealer's License is eligible to apply for an import/export permit. Health Canada's proposed intent to revise the Special Access Programme (SAP) and related regulations to permit certain authorized uses of psilocybin-assisted psychotherapeutic treatments. The intended SAP revision, announced on December 11th, could lead to important new medical applications, particularly in the complex and growing mental health sector.
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